IS/ISO 7197 : 2006 (Superseding IS 14219 : 2001) Indian Standard NEUROSURGICAL IMPLANTS -- STERILE, SINGLEUSE HYDROCEPHALUS SHUNTS AND COMPONENTS ICS 11.040.40 ©BIS 2010 B U R E A U OF I N D I A N STANDARDS MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG NEW DELH1110002 January 2010 Price Group 4 Neurosurgery Instruments, Implants and Accessories Sectional Committee, MHD 07 NATIONAL FOREWORD This Indian Standard which is identical with ISO 7197 :2006 'Neurosurgical implants -- Sterile, single-use hydrocephalus shunts and components' issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendation of the Neurosurgery Instruments, Imp/ants and Asscessories Sectional Committee and approval of the Medical Equipment and Hospital Planning Division Council. This standard was first published as IS 14219:1994/ISO 7197:1989 and was subsequently revised in 2001 due to revision in the corresponding ISO 7197 : 1993. The following modifications have been effected in ISO 7197:2006 and is being published as IS/ISO 7197 : 2006. a) Definition clause has been modified, b) General requirement for shunt has been modified, and c) New clause specific requirement for component has been added. After the publication of this standard, IS 14219 : 2001/ISO 7197 : 1993 'Neurosurgical implants -- Sterile, single-use hydrocephalus shunts and components (first revision)' shall be treated as withdrawn. A shunt is defined as an artificial connection of two compartments inside the body. For the treatment of hydrocephalus, the ventriculo-athal shunt has been introduced initially to control the intraventricular pressure in the brain of patients. Today ventriculo-peritoneal shunts are preferably implanted. In special cases, a lumbo-peritoneal shunt is implanted. Normally a hydrocephalus shunt includes a valve which determines the resulting intraventricular pressure in the brain of the patients and influences the flow rate through the shunt. The following types of valve are currently commercially available. a) Conventional differential-pressure valves (DP-valves) are designed as ball-in-cone valves, membrane valves or silicone slit valves. They have one characteristic opening pressure. If the difference pressure between inlet and outlet exceeds this opening pressure the device opens. After opening, the different types of DP-valve show a wide range of different flow characteristics. Differences due to a changed posture of the patient have no intended impact on the function of the devices. b) Adjustable DP-valves act like conventional DP-valves. In contrast to non-adjustable devices they introduce the possibility of a non-invasive readjustment of the opening characteristic after implantation. They do not take into account changes due to a changed posture of the patient. c) Gravitation valves or hydrostatic devices take into account the changed physics in a shunt due to a changed posture of the patient. These devices aim to avoid an unphysiological negative intraventricular pressure in the upright position of the patient, which might be the consequence of the hydrostatic pressure in shunts with adjustable or not adjustable DP-valves. There are three different hydrostatic devices commercially available: flow-reducing devices, valves with a so-called 'anti-siphon-device' or 'siphon-control-device' and gravity-assisted devices. d) Other adjustable valves, for example: -- Gravitation valves: adjustable hydrostatic devices present in addition to the characteristics of hydrostatic devices {group 4) with the possibility of a non-invasive readjustment of the opening performance of the device; -- Adjustable anti-siphon-device valves; and -- Adjustable flow-readucing valves. (Continued on third cover} IS/ISO 7197 : 2006 Indian Standard NEUROSURGICAL IMPLANTS -- STERILE, SINGLEUSE HYDROCEPHALUS SHUNTS AND COMPONENTS 1 Scope This International Standard specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes and reservoirs. This International Standard gives no recommendation concerning the superiority of a certain type of valve. For manufacturing, it defines the mechanical and technical requirements. This International Standard defines the technical information of the valve, to be given by the manufacturer. In respect to the different principles of the valve types, specific characteristics are defined for each group as declared by the manufacturer. The benefit of this International Standard for the surgeon and the patient is to understand the information given by the manufacturer and to obtain standardized information about the performance of a well working product with new design characteristics. The benefit for the manufacturer is to define the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture. This International Standard does not apply to active implants for the treatment of hydrocephalus. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing ISO 14630:2005, Non-active surgical implants -- General requirement ASTM F2503-05, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 accompanying documents document accompanying a medical device, or an accessory, and containing important information for the user, operator, installer or assembler of the medical device, particularly regarding safety supplied by the manufacturer NOTE Adapted from ISO 14971:2000. 1 IS/lSO 7197 : 2006 3.2 hydrocephalus state of excessive accumulation of cerebro-spinal fluid CSF with the ventricular system of the head due to a disturbance of secretion, flow or absorption 3.3 hydrocephalus shunt single-use device(s) typically consisting of an inflow catheter, a pressure-controlling device, and an outflow catheter intended to regulate the pressure of cerebro-spinal fluid CSF 3.4 instructions for use parts of accompanying documents provided by the manufacturer, giving the necessary information for safe and proper use 3.5 lumbo-peritoneal drainage drainage of cerebro-spinal fluid CSF from the lumbar sub-arachnoid spaces into the peritoneum 3.6 patient identification card card identifying its holder and issuer, which carries data on the hydrocephalus shunt implanted 3.7 ventriculo-atrial drainage drainage of cerebro-spinal fluid CSF from the ventricles into the right atrium of the heart 3.8 ventriculo-peritoneal drainage drainage of cerebro-spinal fluid CSF from the ventricles into the peritoneum 4 General requirements for shunts 4.1 General The sample size shall be justified and stated. 4.2 Radiopacity - All external parts of the shunt or accessory device shall be radiopaque or shall carry radiopaque markers. All parts of the shunt shall be identifiable via X-ray examination. NOTE Guidance can be found in ASTM F640. 4.3 Biocompatibility The biocompatibility of hydrocephalus shunts and components shall be assessed. Guidance is given in the principles and methods recommended in ISO 10993-1. 4.4 Resistance to leakage Resistance to leakage shall be measured using air. All parts of the shunt shall show no signs of leakage with a differential pressure from inside to outside of 9,806 7 kPa (1 m water column) within 5 min. 2 IS/ISO 7197 : 2006 4.5 Control of the implanted shunt The functionality of the shunt and the method of control of the implanted shunt shall be stated in the accompanying documents. If no test is possible, the manufacturer shall state this fact in the instructions for use and the accompanying documents. 4.6 Pressure-flow characteristics of the valve, the components and the pre-assembled shunt The pressure-flow characteristics of the valve shall be tested and monitored in the relevant flow range of (5 to 50) ml/h. A graph showing the pressure/flow characteristics shall be included in the accompanying documents. The manufacturer shall state if the complete system (catheter, reservoir and other devices) causes fundamental changes in the pressure/flow characteristics. In this case, graphs showing the pressure/flow characteristics of the complete shunt and the components shall be included. NOTE 5.2). Fundamental change would be additional resistance due to an inner diameter of the catheter smaller than 1 mm (see If the device shows a posture-dependant function, the basic characteristic for the most important positions should be shown (see 5.1.3). If the characteristic of the device depends on the subcutaneous pressure, the effects on the valve performance should be shown in the relevant ranges [see 8.2 g)]. 4.7 Identification of shunts in vivo The type of the valve as well as the direction of flow shall be detectable non-invasively. A method for the identification of the valve shall be given in the instructions for use and in the patient identification card. For adjustable devices, an X-ray image related to the basic understanding of the pressure settings shall be included in this information. 4.8 Ability to withstand overpressure The functionality and integrity of the shunt shall not be affected by 9,806 7 kPa (1 m water column) positive pressure applied to the open shunt. 4.9 Dynamic breaking strength The dynamic breaking strength of every component of the shunt shall be tested using a frequency of (1 ± 0,2) Hz. The tension shall be applied in flow direction and lead to an elongation of the shunt of 10 % or a maximum force of 5 N whichever comes first. Testing shall be carried out for 100 000 cycles. During this test, no component shall rupture or break. 4.10 Behaviour under MR imaging conditions For each of the components used for the shunt, the manufacturer shall state if it is MR unsafe, MR safe or MR compatible in accordance with ASTM F2503-05. 4.11 Bursting pressure Each component of the shunt shall be capable of withstanding a positive pressure of 19,613 3 kPa (2 m of water column) inside the component without a significant change of its characteristics within a tolerance of 3 IS/ISO 7197 : 2006 + 10 % of each specification. The characteristics shall be in the described range at the latest, two hours after the pressure has been applied. 5 5.1 Specific requirements for components Valves Reflux performance of shunts connecting the ventricle to the blood system 5.1.1 A maximum flow of 0,04 m!/min is allowed to be drained back in a pressure range between 0 and 4,903 3 kPa (0 and 500 mm of water column) against the flow direction. 5.1.2 Long term stability The long term stability of a valve shall be demonstrated according to the following test method: -- -- -- immerse the valve in distilled, degassed water; keep the water temperature at blood temperature ± 5 °C; pump distilled, degassed water at an average flow rate of 20 ml/h through the valve for 28 d. During testing time, the characteristics of the valve (e.g. flow rate or opening pressure) shall remain in the range which is stated in the instructions for use. 5.1.3 Influence of the changed posture of the patient on the valve performance The manufacturer shall state in the instructions for use if the characteristics of the valve depend on the posture of the patient. if the characteristics depend on the posture, the compliance of these characteristics with the values stated by the manufacturer shall be stated for horizontal and vertical position of the patient (see 4.6). 5.2 Resistance of tubing and components In addition to the pressure flow graph of the valve, the manufacturer shall describe the influence of tubing or other additional components in the accompanying documents. NOTE This can be done by an additional pressure-flow diagram. 6 Marking and labelling of shunts The requirements of ISO 14630:2005 11.2, 11.5 and the following shall apply. -- Information on how the opening pressure was measured shall be stated in the accompanying documentation. The characteristic pressure depending performance shall be given at a flow rate of 20 ml/h. -- 7 Packaging The requirements of ISO 14630:2005 Clause 10 shall apply. 4 IS/ISO 7197 : 2006 8 Information supplied by the manufacturer 8.1 Genera) The requirements of ISO 14630:2005 Clause 11 and the following shall apply. 8.2 Instructions for use The instructions for use shall include: a) instructions for the pre- and postoperative testing of the functionality of the shunt; b) warning notices concerning the maximum positive and negative pressure that can be applied to the system without impairing its performance; c) dimensions of components; d) method for puncture and indication on how often a puncture is possible; e) the flow characteristic of the valve shall be given in a pressure versus flow diagram in the range 5 ml/h to 50 ml/h; the measuring method shall be specified; f) if the region in which the shunt is implanted has an influence on the valve characteristics, this shall be indicated and quantified; g) if the flow characteristics depend on the subcutaneous pressure, this shall be indicated; if applicable, include a graph of valve pressure over ambient pressure (between 0 and 0,490 3 kPa (0 and 500 mm water column) measured under constant flow between 10 ml/h and 20 ml/h (medium.production rate of an adult); h) advice on if and how the flow characteristics of the shunt are affected by MR examination; i) advice on if and how the flow characteristics of the adjustable shunt are affected by MR examination including indication of how the performance of the valve is affected by which magnetic field intensity; j) 8.3 instruction if and how the shunt shall be tested and/or readjusted after MR examination. Patient identification card A card, suitable for retention by the patient, shall be provided by the manufacturer. This card shall contain the following: a) information on the shunt (name, manufacturer, type, serial number); b) X-ray image of the shunt; c) X-ray images related to each pressure setting if applicable; d) place for indication of date and location of implantation by the user; e) a warning against the hazards of exposure to magnetic fields; f) instruction if and how the shunt shall be tested and/or readjusted after MR examination. 5 IS/ISO 7197 : 2006 Bibliography [1] [2] [3] ISO 11134, Sterilization of health care products -- Requirements for validation and routine control -- Industrial moist heat sterilization ISO 11135:1994, Medical devices -- Validation and routine control of ethylene oxide sterilization ISO 11137:1995 , Sterilization of health care products-- Requirements for validation and routine control -- Radiation sterilization ISO 11137:1995/Cor. 1:1997, Sterilization of health care products -- Requirements for validation and routine control--Radiation sterilization -- Technical Corrigendum 1 ISO 11137:1995/Amd. 1:2001, Sterilization of health care products -- Requirements for validation and routine control -- Radiation sterilization -- Amendment 1: Selection of items for dose setting ISO 14155-1, Clinical investigation of medical devices for human subjects-- Parti: General requirements ISO 14155-2, Clinical Investigation of medical devices for human subjects-- Part 2: Clinical investigation plans ISO 14971:2000, Medical devices -- Application of risk management to medical devices ASTM F640-79, Standard Test Methods for Radiopacity of Plastics for Medical Use ASTM F647-94, Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application ASTM F2038-00e1, Standard Guide for Silicone Elastomers, Gels and Foams Used in Medical Applications Part I -- Formulations and Uncured Materials ASTM F2042-00e1, Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II -- Crosslinking and Fabrication 1) [4] [5] [6] [7] [8j [9] [10] [11] [12] 1) Shortly to be cancelled and replaced by: ISO 11137-1, Sterilization of health care products-- Radiation-- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137-2, Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose ISO 11137-3, Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects. 6 IS/ISO 7197 : 2006 TECHNICAL CORRIGENDUM 1 Technical Corrigendum 1 to ISO 7197:2006 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 3, Neurosurgical implants. Page 5 8.2 g) the value of pressure in the text should read: "... if applicable, include a graph of valve pressure over ambient pressure [between 0 kPa and 4,903 3 kPa (0 mm and 500 mm water column)]..." 7 IS/ISO 7197 : 2006 NATIONAL ANNEX A (National Foreword) A-1 BIS CERTIFICATION MARKING A-1.1 The product may also be marked with the Standard Mark. A-1.1.1 The use of the Standard Mark is governed by the provisions of the Bureau of Indian Standards Act, 1986 and the Rules and Regulations made thereunder. The details of conditions under which the licence for the use of the Standard Mark may be granted to manufacturers or producers may be obtained from the Bureau of Indian Standards. 8 GMGIPN--379 BIS/ND/2009--300 (Continued from second cover) Although the technical and phenomenological performance of the devices is significantly different, no design has scientifically been proven to be superior. Due to the important technical differences, specific testing procedures are necessary to investigate the performance of the different valves. The text of ISO Standard has been approved as suitable for publication as an Indian Standard without deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following: a) Wherever the words 'International Standard' appear referring to this standard, they should be read as 'Indian Standard'. Comma (,) has been used as a decimal marker in the International Standard while in Indian Standards, the current practice is to use a point (.) as the decimal marker. b) In this adopted standard, reference appears to the following International Standard for which Indian Standard also exists. The corresponding Indian Standard which is to be substituted in its place is listed below along with its degree of equivalence for the edition indicated: international Standard ISO 10993-1 : 2005 Biological evaluation of medical devices -- Part 1: Evaluation and testing Corresponding Indian Standard IS 12572 (Part 1) : 1994 Biological evaluation of medical devices: Part 1 Guidance on selection of tests (first revision) Degree of Equivalence Technically Equivalent The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards and has decided that they are acceptable for use in conjunction with this standard: International Standard ISO 14630 : 2005 ASTM F2503-05 Title Non-active surgical implants -- General requirement Standard practice for marking medical devices and other items for safety in the magnetic resonance environment Technical Corrigendum 1 to the above International Standard has been given at the end of this standard. The standard also makes a reference to the BIS certification marking of the product. Details of which is given in National Annex A. For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2 :1960 'Rules for rounding off numerical values (revised)'. The number of significant places retained in the rounded off value should be same as that of the specified value in this standard. Bureau of Indian Standards BIS is a statutory institution established under the Bureau of Indian Standards Act, 1986 to promote harmonious development of the activities of standardization, marking and quality certification of goods and attending to connected matters in the country. Copyright BiS has the copyright of all its publications. No part of the these publications may be reproduced in any form without the prior permission in writing of BIS. This does not preclude the free use, in the course of implementing the standard, of necessary details, such as symbols and sizes, type or grade designations. Enquiries relating to copyright be addressed to the Director (Publications), BIS. Review of Indian Standards Amendments are issued to standards as the need arises on the basis of comments. Standards are also reviewed periodically; a standard alongwith amendments is reaffirmed when such review indicates that no changes are needed; if the review indicates that changes are needed, it is taken up for revision. Users of Indian Standards should ascertain that they are in possession of the latest amendments or edition by referring to the latest issue of 'BIS Catalogue' and 'Standards: Monthly Additions'. This Indian Standard has been developed from Doc No.: MHD 07 (096).